Deadly workout supplement? Jack3d outside FDA’s reach

Over the past few years, a popular dietary supplement has amassed a cult-like following of fitness enthusiasts across the country. From coast to coast, you can find small white canisters filled with a pink powder tucked into gym bags, stashed in lockers and sitting in kitchen cupboards.

Devotees claim it gives them that extra edge they need to run that elusive last mile, or to lift that extra 10 pounds.

But detractors call it potentially dangerous, perhaps even deadly.

The supplement is called Jack3d (pronounced Jacked), but the ingredient that users say sets it apart from other pre-workout supplements is 1,3 dimethylamylamine – or DMAA. The U.S. Food and Drug Administration says DMAA is illegal.

The FDA has received 86 adverse event reportsÃ‚Â believed to be linked to DMAA. Serious side effects reported to the FDA include depression, anxiety, vomiting, loss of consciousness, chest pain, and even death.

Fabricant’s message about DMAA was clear: “It is an illegal dietary supplement.”

So why is it still being sold in the US?Ã‚Â Fabricant says, Ã¢â‚¬Å“banning it would be, you knowÃ¢â‚¬Â¦itÃ¢â‚¬â„¢s difficult.Ã¢â‚¬Â

The FDA has limited legal authority over supplements. In 1994, a law was passed by the U.S. government that declared dietary supplements exempt from pre-market FDA approval.

Ã¢â‚¬Å“We don’t have pre-market approvalÃ¢â‚¬Â¦we don’t evaluate [dietary supplement] products for safety or efficacy prior to them going to market,Ã¢â‚¬Â said Fabricant in an interview airing Friday, April 12 at 10pm/9CDT on NBC’s Rock Center with Brian Williams.

So what can the agency do?Ã‚Â In 2012, the FDA sent warning letters to 11 manufacturers questioning DMAAÃ¢â‚¬â„¢s safety and challenging their claims that the ingredient even qualifies as a dietary supplement.Ã‚Â All of them voluntarily pulled their products – except for USP Labs, the makers of Jack3d.

In a written statement to NBC News, Michael Petruzzello on behalf of USP Labs maintains that, Ã¢â‚¬Å“DMAA is a safe and lawful dietary ingredient.Ã‚Â We stand by the scientific evidence presented and believe there is no reason to withdraw it from the market.Ã¢â‚¬Â

The company also points to Ã¢â‚¬Å“three published scientific papers [that] document that 1,3 DMAA can be extracted from [a] geranium found in particular areas of China,Ã¢â‚¬Â meaning it is a natural substance, and is therefore not subject to the FDAÃ¢â‚¬â„¢s drug approval process.

Dr. Pieter Cohen, a Harvard professor and member of the Cambridge Health Alliance who studies supplement safety, disagrees with USP Labs that DMAA comes from a plant.

Ã¢â‚¬Å“DMAA has nothing to do with nature Ã¢â‚¬Â¦ That’s an absolute myth perpetuated by companies selling it,Ã¢â‚¬Â he says. Ã¢â‚¬Å“DMAA is a drug that manufacturers are passing off as a plant product.Ã¢â‚¬Â

So if DMAA doesnÃ¢â‚¬â„¢t come from the geranium plant, as USP Labs claims, where does it come from?Ã‚Â Cohen says Ã¢â‚¬Å“DMAA is … produced in a factory.Ã¢â‚¬Â

Debates over DMAAÃ¢â‚¬â„¢s origins aside, Cohen thinks the ingredient should be removed from the market for another reason:Ã‚Â Ã¢â‚¬Å“Could it increase the risk of death? Could it lead to the death of a young healthy man? Absolutely.Ã¢â‚¬Â

Dr. Cohen says DMAA behaves in the body like an amphetamine:Ã‚Â Ã¢â‚¬Å“If you took a low dose of this, you might notice a slight tremor– a little more alert, awakeness, your heart beating a little faster.Ã¢â‚¬Â

He also sees similarities between DMAA and another supplement that was famously banned years ago, Ephedra.

Ã¢â‚¬Å“Now we’re seeing situations in which people are taking this and experiencing adverse events that are completely consistent with those that we saw with Ephedra– the heart attacks, the strokes, the deaths,Ã¢â‚¬Â Cohen said.

In response to questions about the safety of DMAA, USP Labs had this to say: Ã¢â‚¬Å“The company is unaware of a single corroborated serious adverse event [associated with DMAA] when used in accordance with labeled directions for use,” and that there are “eight peer-review published clinical studies detailing the safety of DMAA.”

DMAA has been banned in the United Kingdom, Canada, Australia and six other countries. It is also prohibited for use by athletes by many sports organization in the United States, as well as the by the International Olympic Committee. The U.S. Military now prohibits the sale of DMAA on all bases, after two soldiers who used the product died.

One of those soldiers was Private Michael Sparling. On a June morning in 2011, Sparling went for a training run on his base compound in Fort Bliss, Texas. It was comfortable 70 degree weather and the 3.5 mile circuit was nothing unusual for the young, fit soldier.

Later that morning, MichaelÃ¢â‚¬â„¢s mother Leanne received a phone call sheÃ¢â‚¬â„¢ll never forget.Ã‚Â It was the commander of the base hospital, calling to tell her that her son was in cardiac arrest. While preparing to fly to her sonÃ¢â‚¬â„¢s bedside in Texas, Leanne called the hospital for an update on his condition.

“Ma’am, we’ve done everything we could to save him but at 11:17 this morning he passed away.”

Michael Sparling was 22 years old. Grief-stricken, the Sparling family looked for answers. What could have caused their young, seemingly healthy son to die so suddenly?

During the autopsy, tests confirmed the presence of the substance DMAA in Michael SparlingÃ¢â‚¬â„¢s blood.Ã‚Â Army doctors told the Sparlings that the substance may have played a role in his death.

He had only been using the product for a month before he died.

But even tragic stories like that of Michael Sparling, and the threat of possible side effects like heart failure and cerebral hemorrhage arenÃ¢â‚¬â„¢t enough to scare off many enthusiastic Jack3d users.Ã‚Â In 2011, more than $100 million worth of DMAA-based products were sold in the United States.

Keith Stewart is a 24 year-old marketing manager in New York City who uses Jack3d almost daily as a part of his fitness routine.Ã‚Â After work, Stewart heads to his apartment in lower Manhattan, takes the recommended dose of Jack3d, and quickly heads to the gym.Ã‚Â HeÃ¢â‚¬â„¢s got the timing of when he takes Jack3d down to a science, and wonÃ¢â‚¬â„¢t let anything get in between him and his work out.

Ã¢â‚¬Å“Within 30 minutes, you feel this rush of energy in your body and you just have to move.Ã‚Â You basically have to lift things, move things, get it out of your system Ã¢â‚¬Â¦ I take it, and I know 30 minutes later, if I’m not in the gym, I’m going to start to feel antsy.

“Your body will start to tingle. Your skin starts to tingle, actually Ã¢â‚¬Â¦ you can feel it in your veins. You feel this rush of energy in your body and you just have to move,Ã¢â‚¬Â says Stewart.

Ã¢â‚¬Å“Once I took it actually and I couldn’t get to the gym, and, uh, I just remember I had to run.Ã‚Â I just started running down the street, um, and doing like a work out in my own park, so, it was, uh.Ã‚Â That was when I noticed that, wow this stuff is really powerful.Ã¢â‚¬Â

Powerful and available over the counter at many local supplement stores, like retail giant GNC.

GNC also declined our request for an interview, but had this to say: Ã¢â‚¬Å“GNC has no reason to believe that DMAA is unsafe.Ã‚Â GNC, as a responsible retailer, does not sell products that contain substances banned by the FDA or that have been recalled by the FDA.Ã¢â‚¬Â

While itÃ¢â‚¬â„¢s true that DMAA is not a banned substance, Cohen feels the company has a responsibility to protect its customers.

Ã¢â‚¬Å“ItÃ¢â‚¬â„¢s shocking that GNC continues to support USP Labs in selling their wares,Ã¢â‚¬Â Cohen said.

The parents of Michael Sparling say they arenÃ¢â‚¬â„¢t waiting for the FDA to ban DMAA, or for GNC to voluntarily pull Jack3d from its shelves.Ã‚Â They are suing both USP Labs and GNC for causing their sonÃ¢â‚¬â„¢s death.Ã‚Â Ã‚Â USP Labs has moved to dismiss the lawsuit.Ã‚Â Regarding the two military deaths, USP Labs says, “There is absolutely no evidence to support the assertion that 1,3 DMAA had anything to do with those unfortunate deaths.”

In a statement, GNC told Rock Center that the company relies on manufacturers to warrant Ã¢â‚¬Å“that the products are fully compliant with all applicable laws andÃ¢â‚¬Â¦safe for human consumption.Ã¢â‚¬Â

And for the past two years, MichaelÃ¢â‚¬â„¢s mother has been dropping into supplement stores to find out if theyÃ¢â‚¬â„¢re still selling the product she believes killed her son.Ã‚Â She told us about a conversation she had with a clerk a few months after MichaelÃ¢â‚¬â„¢s death:

Ã¢â‚¬Å“I said, Ã¢â‚¬ËœWell, I’m interested in a product called Jack 3D, or Jacked?Ã¢â‚¬â„¢Ã‚Â And he goes, Ã¢â‚¬ËœOh yes.Ã¢â‚¬â„¢ And he became very animated,Ã¢â‚¬ÂÃ‚Â she said.

Leanne says the clerk told her it was the storeÃ¢â‚¬â„¢s top seller.Ã‚Â She asked him if he had heard of any adverse side effects from using the product.Ã‚Â Ã¢â‚¬Å“And he goes, Ã¢â‚¬ËœNo, it is 100% natural, it’s totally safeÃ¢â‚¬Â¦Are you buying it for your son?Ã¢â‚¬â„¢Ã¢â‚¬Â

Leanne Sparling pointed to the dog tags around her neck and said, Ã¢â‚¬Å“Do you see the dog tags I wearÃ¢â‚¬Â¦They were my son’s Ã¢â‚¬Â¦ He died after taking this product.”